Kornimate/medical-research-clean huggingface dataset:
phasei/ii investigator-initiated trial to investigate safety and efficacy of ripasudil in patients with retinopathy of prematurity

Conditions: Retinopathy of Prematurity

Summary: this is an open-label, single-arm phase i/ii trial to evaluate the safety and efficacy of rho-associated protein kinase(rock) inhibitor ripasudil eye drops for preterm infants with retinopathy of prematurity(rop).

ripasudil eye drops will be administrated to all enrolled preterm infants with zone i/ii stage 1 or greater rop （except for aggressive posterior rop, type1 rop ）. the safety and efficacy of ripasudil in treated patients will be assessed in comparison to a historical control.

Eligibility criteria:
inclusion criteria: * 1. informed consent signed by parents or legal guardians of the patient * 2. patients born with less than or equal to 32 weeks of gestational age and/or less than or equal to 1,500 grams of birth weight * 3. patients with the following types of rop in both eyes 1. zone i rop with stage greater than or equal to 1 2. zone ii rop with stage greater than or equal to 1 exclusion criteria: * 1. patients with aggressive posterior rop in one or both eyes * 2. patients with type 1 rop in one or both eyes * 3. patients with a confirmed or suspected chromosomal abnormality or genetic disorder * 4. history of hypersensitivity to ripasudil (including drugs with similar chemical structure) in patients or their mothers * 5. patients or their mothers have participated in another intervention study and have used the study drug of another intervention study within 30 days prior to enrollment in this study or within 5 times the half-life of the study drug * 6. patients with an ocular structural abnormality that can affect the evaluation of this clinical study by investigators * 7. patients with a clinically significant neurological disease (e.g., intraventricular hemorrhage grade 3 or higher, severe hydrocephalus with significantly increased intracranial pressure) * 8. patients with inadequate blood access * 9. patients with complications, allergies, or worsening systemic conditions that make it difficult to conduct this trial * 10. patients judged unsuitable by investigators

Keywords: retinopathy of prematurity rop
novel dementia biomarkers

Conditions: Alzheimer Disease, Early Onset

Summary: the study will investigate structural and functional characteristics of the brain of dementia patients compared to healthy controls in order to get a better insight into importance of early biomarkers for the diagnosis of alzheimer's dementia. the methods for obtaining biomarkers incude magnetic resonance imaging (mri), near-infrared spectroscopy (fnirs) and electroencephalography (eeg), electrocardiography (ecg) and neurophyshological assessments. special parameters are being studied that have already been shown to detect changes in the early stages of alzheimer's dementia.


Eligibility criteria:
inclusion criteria: * clinically diagnosed mci patients and matched healthy controls exclusion criteria: * metal in body and tatoos; * other chronic systemic neurological, cardiologic, metabolic or musculo-skeletal diseases which have been proven to influence the outcome variables * alcohol abuse * colour blindness * pregnancy * surgery in the last 6 months * uncorrected vision
stereotactic margins in localized bronchial cancer (t1/t2a, n0)

Conditions: Bronchial Cancer

Summary: bronchopulmonary cancer is the first cause of mortality in the world. we want to update the margins used in stereotactic radiotherapy, in the context of localized lung cancer, of non-surgical management. the investigators wish to redefine the stereotactic radiotherapy margins according to the histological type in localized non-small cell lung cancer. indeed, these criteria were previously defined on a smaller cohort, in the context of 3d radiotherapy (mainly t3, t4 tumors). in addition, the incidence of radiation pneumonitis is highly dependent on the irradiated lung volume, which in turn depends on the ctv margins used.


Eligibility criteria:
inclusion criteria: * major subject (≥18 years old) * subject operated on at hus for t1/t2a n0 stage lung adenocarcinoma or squamous cell carcinoma before 30/09/2019 * ct scan available on the hus imaging server or on cd * subject who has not expressed opposition to the use of his or her data for research purposes exclusion criteria: * subject who has expressed opposition to participating in the study * impossibility to give the subject informed information (difficulties in understanding the subject, ...) * subject under legal protection * subject under guardianship or curatorship

Keywords: bronchial cancer bronchopulmonary cancer stereotactic radiotherapy stereotactic ctv margins cell lung cancer 3d radiotherapy
csmart liquid biopsy and dynamic monitor of nsclc patients in inner-mongolia china

Conditions: Nonsmall Cell Lung Cancer; Adenocarcinoma

Summary: the purpose of this study is to evaluate the mutation pattern of epidermal growth factor receptor (egfr) and other tki targeted gene during tki treatment of advanced nsclc patient with liquid biopsy.

in the study, 200 advanced nsclc patients will be recruited. all the patients will receive biopsy genotype assay and circulating single-molecule amplification and resequencing technology (csmart) liquid biopsy. those patients who carry egfr activating mutation and other tki targeted activating mutation will receive tki treatment. during the tki treatment, every patients will take liquid biopsy assay to monitor the mutation status. the study will be ended when all the patients had a progressive disease (pd) in their targeted lesion

Eligibility criteria:
inclusion criteria: * nsclc adenocarcinoma patients confirmed by pathologist * initial, non-operative patients with stage iii \& iv adenocarcinoma * older than 18 years old * subjects have no major organ dysfunction. in detail, liver function: tbil≤1.5 uln ( upper limit of normal); serum gpt (glutamate-pyruvate transaminase ):≤2 uln, renal function: scr≤1.2 uln; bun≤1.2 uln, bm (bone marrow) reserve: wbc (white blood cell count) ≥4.0×e9/l; anc≥2.0×e9/l，plt≥100×e9/l，hgb≥100g/l. ps (performance status) score: less than 2, expected survival time: more than 3 months; * have a clear measurable tumor lesion in lung,under riest. * without severe drug allergy * patients participate in this trail must sign the informed consent exclusion criteria: * patients with brain metases related syndrome * patients with bone metases related complication * patients with cognitive disorder * patients with major organ dysfunction and severe cardiopathy include congestive heart-failure, uncontrolled arrhythmia, angina with long term treatment, vhd (valvular heart disease), myocardial infraction, rhtn (resistant hypertension). * patients with other severe complication and excluded by the researcher. * patients who are allergy with the tki in this trail. * patients who participated in other trails or with anti-tumor treatments * patients who receive radiotherapy at the site of curative effect observation * patients who receive allogenic blood transfusion within 14 days

Keywords: nsclc tki mutation liquid biopsy
varenicline-aided cigarette reduction in smokers not ready to quit

Conditions: Tobacco Use Disorder

Summary: the investigators will randomize smokers to receive 1) varenicline + smoking cessation/reduction counseling or 2) placebo pill + smoking cessation/reduction counseling. neither the participants nor the research therapists/evaluators will know to which condition (active or placebo pill) the participants have been assigned i.e., a double-blind study). the medication and weekly counseling will occur for 28 days. participants will complete assessment measures just before the start of treatment (baseline), at the end-of-treatment, at 1-month, 3-month, and at 6-months to determine if there are differences in tobacco use between treatment groups.


Eligibility criteria:
inclusion criteria: * must smoke at least 10 cigarettes per day for past 6-months * must have a working cellular or land-line phone exclusion criteria: * must not be thinking of quitting in the next 30 days, but be interested in cutting down- must not regularly (more than 1x/month) use tobacco products other than cigarettes * must not be currently receiving tobacco dependence treatment counseling * must not currently be taking varenicline, bupropion, nortriptyline, or any nicotine preparations (gum, lozenge, patch, spray, inhaler) * must not have positive screen on scid-i/np psychotic screen * must have no contraindications to using varenicline, including pregnancy, as measured by medical history form

Keywords: tobacco nicotine cigarette smoking
risk factors for shoulder pain and emesis after laparoscopic cholecystectomy

Conditions: Shoulder Pain; Nausea; Vomiting

Summary: risk factors for postoperative shoulder pain after laparoscopic cholecystectomy were not clear. moreover, risk factors for postoperative emesis specially for this surgery were not detailed and accurate. the present study is a prospective cohort study to identify risk factors for shoulder pain and emesis within 24 hours in chinese patients after laparoscopic cholecystectomy under general anesthesia.

the present study is a prospective cohort study to identify risk factors for shoulder pain and emesis within 24 hours in chinese patients after laparoscopic cholecystectomy under general anesthesia.

Eligibility criteria:
inclusion criteria: * \> 21 years old, * chinese patient exclusion criteria: * current pregnancy, * patients with history of upper laparotomy, * inability to communicate before operation, * persistent emesis or shoulder pain before operation, * patients who converted to open cholecystectomy, * receiving postoperative ventilator support, * unstable postoperative condition or major complications.

Keywords: laparoscopic cholecystectomy, elective anesthesia, general shoulder pain nausea vomiting laparoscopic cholecystectomy general anesthesia
a prospective study with a new device for the monitoring of cerebral oxygenation on cardiac surgery patients

Conditions: Coronary Artery Disease; Heart Valve Disease

Summary: the purpose of this study is to determine whether a new cerebral oxygenation monitoring device is comparatively similar to the current approved devices.

cerebral oxygenation monitoring is an innovative way to monitoring cardiac surgery patients intraoperatively to reduce the incidence of postoperative hypoxic side effects. there are a number of approved devices already in the market that have proved their efficacy.

Eligibility criteria:
inclusion criteria: 1. to be 18 years old or older 2. scheduled for cardiac surgery 3. treatment will include 72 hours or more of hospital stay 4. understand enough about the risks and benefits of the study to be able to make an informed decision before agreeing to be in the study exclusion criteria: 1. history of cerebrovascular disease 2. history of skin problems on forehead (skin rashes, acne, allergies, etc.) 3. history of craniofacial surgeries 4. pregnancy

Keywords: hypoxia cerebral hypoxia
efficacy of oral ivabradine in patients presenting with nstemi

Conditions: NSTEMI

Summary: this study aims to evaluate the beneficial effect of heart rate reduction of oral ivabradine in patients presenting with non st-segment elevation myocardial infarction (nstemi) during acute stage post percutaneous coronary intervention versus conventional treatment. materials and methods: a total of 100 patients admitted to the emergency department, national heart institute, cairo, egypt were randomized into two groups as follows: group a: 50 patients with nstemi treated with ivabradine (5mg twice daily) in addition to the conventional treatment; group b: 50 patients with nstemi treated with the conventional treatment only. demographic data, detailed history, clinical examination, chest pain onset, blood pressure, heart rate (hr), temperature and respiratory rate, electrocardiogram (ecg) as well as echocardiography and laboratory investigations were recorded. patients were monitored for a period of 3-5 days (acute stage).


Eligibility criteria:
inclusion criteria: * patients with nstemi with normal sinus rhythm and heart rate (hr) more than 70 beats per minute (bpm) and systolic blood pressure (sbp) \>90 mm hg undergoing pci exclusion criteria: * patients needing urgent cardiac surgery, iv inotropic agents or had a hr less than 60 bpm without any medication.
gdm patients and serum amyloid a and interleukin-1 (il-1) receptor antagonist

Conditions: Gestational Diabetes

Summary: serum amyloid a and interleukin-1 (il-1) receptor antagonist (a-saa and il-1ra) values; * comparison of pregnant women with and without gdm diagnosis * comparison of insulin therapy and diet-regulated gdm patients * comparison of pregnant women with and without lga (large gestational age) * comparison of pregnant women with and without polyhydroamnios * investigation of its effect on pregnancy prognosis * in the prediction of gdm diagnosis, it is aimed to study the sensitivity and specificity of both parameters and cut off values. (in gdm patients, liver and kidney function parameters will also be evaluated with a-saa and il-1ra levels).


Eligibility criteria:
inclusion criteria: * patients with 50 gr ogtt + 100 gr ogtt + at 24-28 weeks of gestation * patients with 75 gr ogtt + at 24-28 weeks of gestation * 18-42 years pregnant women exclusion criteria: * any infection * any known fetal chromosomal or structural anomaly * preterm membrane rupture * preterm delivery * preeclampsia or eclampsia * placenta previa

Keywords: gestational diabetes serum amyloid a interleukin-1 (il-1) receptor antagonist
assessment and prevention of caregiver burden in oncology

Conditions: Oncology; Caregiver Burden

Summary: the goal of this randomized, open and controlled supportive care study is to see if we can reduce the burden on the caregiver by offering the caregiver systematic and regular support from the nurse (apn, nurse coordinator in french health care organisations) compared to a support focused on the patient. at the same time, we will also evaluate the impact of this personalised support for the caregiver on their anxiety and quality of life. participants will caregivers of a patient who started a line (any line) of systemic treatment for a solid tumour since less than 3 months or in an active palliative situation since less than 1 month. researchers will compare 2 groups : a group where caregivers benefit from specific nursing support and a group of caregivers with no specific nursing support. the specific support includes 3 mandatory on-site nursing consultations with the patient's caregiver and interviews once a month with a nurse either by phone, on-site consultation or teleconsultation.


Eligibility criteria:
inclusion criteria: * caregiver designated by the patient; * caregiver of a patient who started a line (any line) of systemic treatment for a solid tumour since less than 3 months or in an active palliative situation since less than 1 month; * caregiver of patient already cared for by a nurse before inclusion or going to start a nursing follow-up; * caregiver of a patient with a score ≥2 of social fragility and/or psychological fragility and/or nutritional fragility and/or complexity; exclusion criteria: * patient whose life expectancy is assumed to be \< 6 months; * patient living in an institution (ehpad, mas, ssr, mco, usld) at inclusion; * caregiver declared as having a pathology that could alter his/her capacity to support (psychiatric history, dementia...) or under guardianship.

Keywords: nurse supportive care zarit scale caregiver burden
fetal cardiac remodeling in singleton pregnancies conceived by assisted reproductive technology (biopsied and non-biopsied icsi) versus those normally conceived

Conditions: Fetal Cardiac Disorder

Summary: the study aims to assess the presence of fetal cardiac remodeling and dysfunction in singleton pregnancies conceived by assisted reproductive technology (biopsied and non-biopsied icsi) as compared with those conceived spontaneously (sc).

for gynecologists, reaching a conclusion about fetal cardiac remodeling and dysfunction in singleton pregnancies conceived by assisted reproductive technology (biopsied and non-biopsied icsi) or conceived spontaneously (sc) that would influence the clinical decision and best practice. besides enriching the clinical evidence in fetal cardiac remodeling and dysfunction. for society, the conclusion and recommendation shall maximize the benefits and managing the benefits of the technique used. moreover, providing more information for fetal cardiac remodeling and dysfunction.

Eligibility criteria:
inclusion criteria: 1. women aged \>18 years 2. singleton pregnancy 3. women who are willing and able to attend serial ultrasonographic examinations during the whole pregnancy 4. women willing to sign an informed consent exclusion criteria: 1. multiple pregnancies; more than one fetus 2. any maternal medical disease, including asthma, chronic hypertension, diabetes mellitus, heart disease, extracardiac anomalies, human immunodeficiency virus or hepatitis infection, immunological disorders, lupus, and thyroid disease 3. diagnosis of fetal malformations; fetus with a structural or chromosomal anomaly 4. fetus with small-for-gestational-age (sga) or intrauterine growth restriction (iugr) (a fetal weight that is below the 10th percentile for gestational age) as determined through an ultrasound. 5. smokers or drug/alcohol women 6. inability to understand and provide written informed consent

Keywords: fetal echocardiography
safety of catheter lock with or without heparin in implanted central venous catheters

Conditions: Oncology, Medical; Hematologic Disease

Summary: long-term central venous access devices are considered as safe for the administration of medication as chemotherapy, but are also used for blood sampling. for years these catheters have been locked with a heparin solution in order to avoid occlusion. however, no scientific evidence supports heparin locking when the device is not in use. advanced technology as needleless caps and valved catheters and port reservoirs confirms this trend to use 'saline only' for locking these devices. therefore the investigators hypothesize is that there will be no difference in proportion of occlusions and catheter related bacteremia in long-term venous access devices locked with 'saline only' versus with heparin.


Eligibility criteria:
inclusion criteria: * oncology and hematology patients * life expectancy of minimum of 180 days exclusion criteria: * second or femoral long-term central venous access device * known allergy to heparin (hit) * coagulation disorders(inr \>2, blood platelets \> 1,000,000/mm3) * therapeutic intravenous heparin administration

Keywords: catheters, indwelling catheterization, central venous withdrawal occlusion heparin lock
in vitro studies of immunological and stem cell function in peripheral blood mononuclear cells in patients

Conditions: Immunologic Deficiency Syndrome; Leukemia; Lymphoma; Neoplasm

Summary: peripheral blood mononuclear cells (pbmc) will be collected from patients who have leukemia or lymphoma or other medical conditions involving altered lymphohematopoietic stem cell or immunological function. these pbmc will be assessed for cellular markers by flow cytometry and will be studied for in vitro t helper, effector and suppressor cell functions, to determine whether cell mediated immunity is involved in the condition, or indicative of therapeutic efficacy or is predictive for outcome. peripheral blood stem cells (pbsc) from untreated donors and from cytokine treated donors will be assessed for cellular markers and in vitro growth characteristics that might be useful for identifying normal stem cell populations.

peripheral blood mononuclear cells (pbmc) and mobilized peripheral blood stem cells (pbsc) will be collected from patients who have leukemia or lymphoma or other medical conditions involving altered lymphohematopoietic stem cell or immunological function. these pbmc will be assessed for cellular markers by flow cytometry and will be studied for in vitro t helper, effector and suppressor cell functions, to determine whether cell mediated immunity is involved in the condition, or indicative of therapeutic efficacy or is predictive for outcome. pbsc will be assessed for cellular markers and in vitro growth characteristics that might be useful for identifying normal stem cell populations. furthermore the capacity of stem cells to reconstitute the t lymphocyte lineage will be assessed using ex vivo explant cultures established with thymic or secondary lymphoid tissues.

Eligibility criteria:
patients obtained from collaborators within and outside the nci.

Keywords: transplantation cancer cellular immunity stem cell function immunodeficiency
mri for detecting cancer in women who are at high risk of developing breast cancer

Conditions: Breast Cancer

Summary: rationale: screening tests may help doctors detect cancer cells early and plan more effective treatment for breast cancer. diagnostic procedures such as mri may improve the ability to detect breast cancer. purpose: screening and diagnostic trial to study the effectiveness of mri scans in women who are at high risk for developing breast cancer.

objectives: * estimate the diagnostic yield and positive predictive value of breast magnetic resonance imaging (mri) for the detection of cancer in women who are at greater than 25% lifetime risk for developing breast cancer. * compare the diagnostic yield and positive predictive value of mri with conventional breast cancer screening (mammography and physical examination) for the detection of breast cancer in women with a greater than 25% lifetime risk of developing breast cancer. outline: all patients receive a physical exam within 90 days of initial mri scan. patients undergo a two view screening mammogram within 3 months prior to study entry. patients undergo an mri with gadolinium contrast at entry. all lesions identified as suspicious on physical examination, mammography, or mri undergo a core needle or excisional biopsy. projected accrual: a total of 200 patients will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: * patients at greater than 25% lifetime risk for breast cancer on the basis of family history or a genetic test * prior breast cancer allowed if patient meets the greater than 25% lifetime risk * patients with greater than 5 years since diagnosis must have at least 50% probability for developing breast cancer by the couch model or be positive for brca1 or brca2 mutation * hormone receptor status: * not specified patient characteristics: age: * 25 and over sex: * female menopausal status: * not specified performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * no contraindications to mri scan including patients with pacemakers, magnetic aneurysm clips or other implanted magnetic devices, or severe claustrophobia * not pregnant prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * not specified radiotherapy * not specified surgery * not specified

Keywords: breast cancer